Clinical Trials Administrator Archives – October 1, 2008
October 1, 2008
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Judge's ruling may have ominous repercussions in CT industry
A recent judge's ruling has shaken up the clinical research industry as experts try to determine how the court's interference in an investigational drug study might impact future CT recruitment. -
When does 'compassionate use' help with options?
What often are called "compassionate use" drugs are investigational new drugs (INDs) in later phase trials where the FDA has allowed the sponsor to apply for an individual treatment IND. -
CT site recruits and retains meth group
Methamphetamine ("meth") addicts are one of the more difficult research populations to recruit both for the erratic lifestyles many have and the illicit drug's tendency to make people paranoid. -
Retention rate good for difficult population
One of the key strategies to retaining clinical trial enrollment, particularly when the participants are from vulnerable populations, is exhibiting respect and a nonjudgmental attitude during all encounters, an expert says. -
Compliance Corner: Improve clinical trial billing through systematic process
Before Emory University in Atlanta completely revamped its clinical trials billing process, most of the CT budgeting and analyses were done by individual departments. -
A novel program for next generation of PIs
Biomedical research has become so sophisticated in the 21st century that future principal investigators (PIs) might need to have in-depth knowledge about more than one discipline in order to stay competitive. -
PI finds board policies toughen over study time
It's one thing to sense that IRBs are demanding more and are becoming more cautious during protocol reviews. But it's the rare principal investigator who has a long, multi-site study in which it's readily apparent that the IRB reviews have become more rigorous.